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Approved
Approval ID

6e4ab3d3-378e-40e5-a6a5-66090edcfda8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 28, 2025

Manufacturers
FDA

MELON BIO-TECH (THAILAND) CO., LTD.

DUNS: 662604806

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Salicylic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85588-101
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2025
FDA Product Classification

INGREDIENTS (6)

BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CENTELLA ASIATICAInactive
Code: 7M867G6T1U
Classification: IACT
SALICYLIC ACIDActive
Quantity: 0.5 g in 100 g
Code: O414PZ4LPZ
Classification: ACTIB
CALCIUM CARBOXYMETHYL CELLULOSEInactive
Code: UTY7PDF93L
Classification: IACT

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MY BEAUTY SPOT Day and Night Acne Patch - FDA Drug Approval Details